Long acting injections and implants improve therapy, enhance patient compliance, improve dosing convenience, and are the most appropriate formulation choice for drugs that undergo extensive first pass metabolism or that exhibit poor oral bioavailability. An intriguing variety of technologies have been developed to provide long acting injections and implants. Many considerations need to go into the design of these systems in order to translate a concept from thelab bench to actual therapy for a patient. This book surveys and summarizes the field.. Topics covered in Long Acting Injections and Implants include the historical development of the field, drugs, diseases and clinical applicationsfor long acting injections and implants, anatomy and physiology for these systems, specific injectable technologies (including lipophilic solutions, aqueous suspensions, microspheres, liposomes, in situ forming depots and self-assembling lipid formulations), specific implantable technologies (including osmoticimplants, drug eluting stents and microfabricated systems), peptide, protein and vaccine delivery, sterilization, drug release testing and regulatory aspects of long acting injections and implants. This volume provides essential information for experienced development professionals but was also written to be useful for scientists just beginning work in the field and for others who need an understanding of long acting injections and implants. This book will also be ideal as a graduate textbook. Provides a comprehensive overview of the scientific and regulatory challenges. Gives description of the types of systems, major areas of current application and research together with current commercial applications. The reader isintroduced to the host response to biomaterials/foreign body and the influence of environmental conditions on the design and development of long acting injections and implants. INDICE: An Introduction to Long Acting Injections and Implants. HistoricalOverview of Long Acting Injections and Implants. Host Response to Long ActingInjections and Implants. Anatomy and Physiology of the Injection Site – Implications for Extended Release Parenteral Systems. Drugs for Long Acting Injections and Implants. Diseases and Clinical Applications that Can Benefit from Long Lasting Implants and Injections. Oily (lipophilic) Solutions and Suspensions. Aqueous Suspensions. In Situ Forming Systems (Depots). Microsphere Technologies. Liposomes as Carriers for Controlled Drug Delivery. Micro- and Nanoemulsions (Controlled Release Parenteral Drug Delivery Systems). Nanosuspensions. PEGylated Pharmaceutical Nanocarriers. Protein PEGylation. Self-Assembling LipidFormulations. Implantable Drug Delivery Systems Based on the Principles of Osmosis. Microtechnologies for Drug Delivery. Drug Eluting Stents. Delivery of Peptides and Proteins via Long Acting Injections and Implants. Injectable PLGA Systems for Delivery of Vaccine Antigens. Methods of Sterilization for Controlled Release Injectable and Implantable Preparations. In Vitro Drug Release Testing and In Vivo/In Vitro Correlation for Long Acting Implants and Injections.Regulatory Issues and Challenges Associated with the Development of Performance Specifications for Modified Release Parenteral Products.
- ISBN: 978-1-4614-0553-5
- Editorial: Springer New York
- Encuadernacion: Cartoné
- Páginas: 492
- Fecha Publicación: 28/10/2011
- Nº Volúmenes: 1
- Idioma: Inglés